Dutasteride in Treating Patients With Recurrent Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy

NCT ID: NCT00403000

Last Updated: 2013-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2013-04-30

Brief Summary

RATIONALE: Dutasteride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well dutasteride works in treating patients with recurrent prostate cancer that did not respond to androgen-deprivation therapy.

Detailed Description

OBJECTIVES:

Primary

• Evaluate the time to disease progression in patients with recurrent prostate cancer that progressed during androgen-deprivation therapy who are treated with dutasteride.
• Evaluate the toxicity of dutasteride in these patients.

Secondary

• Evaluate the serum prostate-specific antigen (PSA) level and objective radiographic response rate in patients treated with dutasteride.
• Determine the survival of patients treated with dutasteride.
• Determine the quality of life of patients treated with dutasteride.

OUTLINE: Patients receive oral dutasteride once daily until disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then every 3 months thereafter.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

dutasteride

Oral

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• No other prior systemic therapies, except androgen-deprivation therapy (i.e., orchiectomy or LHRH analogues only) or antiandrogens

• Surgery, brachytherapy, external-beam radiotherapy, and cryotherapy are not considered systemic therapies
• No other concurrent anticancer therapy
• No concurrent use of any of the following:

• Finasteride
• Other investigational 5α-reductase inhibitors
• Anabolic steroids
• Alpha-receptor blockers (e.g., indoramin, tamsulosin hydrochloride, prazosin, terazosin, alfuzosin hydrochloride, and doxazosin)
• Drugs with antiandrogenic properties (e.g., spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, metronidazole, and progestational agents)
• Products containing selenium ≥ 75 mcg or vitamin E ≥ 100 IU
• Saw palmetto
• EG6761
• No concurrent radiotherapy, including palliative radiotherapy for pain control

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James L. Mohler, MD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

References

Shah SK, Trump DL, Sartor O, Tan W, Wilding GE, Mohler JL. Phase II study of Dutasteride for recurrent prostate cancer during androgen deprivation therapy. J Urol. 2009 Feb;181(2):621-6. doi: 10.1016/j.juro.2008.10.014. Epub 2008 Dec 16.

Reference Type: RESULT

PMID: 19091347 (View on PubMed)

Other Identifiers

RPCI-I-34904

Identifier Type: -

Identifier Source: secondary_id

CDR0000514492

Identifier Type: -

Identifier Source: org_study_id